1. PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and
Market Analysis Event-Driven Update
Report Details:
Published:November 2012
No. of Pages: 127
Price: Single User License – US$4995
PharmaPoint: Rheumatoid Arthritis - Japan Drug Forecast and Market Analysis Event-Driven
Update
Summary
GlobalData has released its new Country report, “PharmaPoint: Rheumatoid Arthritis - Japan Drug
Forecast and Market Analysis Event-Driven Update”. The RA market is currently very dynamic,
with the November 6, 2012 FDA approval of Pfizer’s Xeljanz (tofacitinib) and novel oral therapies
awaiting approval such as: Eli Lilly’s anti-BAFF, tabalumab and JAK1,2 inhibitor, baricitinib, and
Rigel/AZ’s SYK inhibitor, fostamatinib. These compounds will challenge the current biologics in the
attempt to dislodge the stronghold of the TNF inhibitors, if their safety and efficacy profiles are
proven once they enter the market.
Japanese physicians surveyed for this report follow guidelines such as ACR or guidelines from the
Japanese Rheumatology Association, but also follow their own clinical experience. However,
diagnosis of mild RA in Japan begins with the PCP or other specialists, then progresses to referral
to a rheumatologist. Interestingly, in Japan, internists and orthopedic surgeons may be the treating
physicians as rheumatology is a rare specialty, though gaining more popularity (Miyasaka, 2011).
Also, most people seeking treatment are 35 years and older. Within this age group, female and
male distribution is comparable.
Scope
- Overview of RA, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment
guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in Japan including product description, safety and efficacy
profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2011 to 2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan

2. rheumatoid arthritis market.
Reasons to buy
- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for
rheumatoid arthritis
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising
sales potential
- Make more informed business decisions from insightful and in-depth analysis of rheumatoid
arthritis drug performance in Japan
- Obtain sales forecast from 2011-2022 in the Japan
Get your copy of this report @
http://www.reportsnreports.com/reports/213172-pharmapoint-rheumatoid-arthritis-japan-drug-forecast-and-
market-analysis-event-driven-update.html
Major points covered in Table of Contents of this report include
1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 11
3.1.3 Prognosis 14
3.1.4 Quality of Life 14
3.2 Symptoms 15
4 Disease Management 16
4.1 Treatment Overview 19
4.2 Japan 23
4.2.1 Diagnosis 23
4.2.2 Clinical Practice 23
5 Competitive Assessment 25
5.1 Overview 25
5.2 Strategic Competitor Assessment 25
5.3 Product Profiles - Major Brands 27
5.3.1 Enbrel (etanercept) 27
5.3.2 Humira (adalimumab) 33

3. 5.3.3 Remicade (infliximab) 36
5.3.4 Simponi (golimumab) 40
5.3.5 Cimzia (certolizumab pegol) 44
5.3.6 Orencia (abatacept) 48
5.3.7 Actemra/RoActemra (tocilizumab) 52
5.3.8 Rituxan/MabThera (rituximab) 56
5.3.9 Methotrexate Sodium (numerous generic names) 59
5.3.10 DMARDs 62
6 Opportunity and Unmet Need 63
6.1 Overview 63
6.2 Unmet Needs 64
6.2.1 More Rheumatologists in the Field and Physician Knowledge of the Disease 64
6.2.2 More Cost-Effective Therapies through Oral Formulation and Biosimilars 64
6.2.3 The Development of Predictive Tests and Discovery of Biomarkers 64
6.2.4 The Discovery of Curative Therapies 65
6.2.5 Improved Drug Safety and Efficacy Profiles 65
6.3 Gap Analysis 66
6.4 Opportunities 67
6.4.1 Predictive Tools for Diagnosis and Treatment 67
6.4.2 Target Specificity 67
7 Pipeline Assessment 68
7.1 Overview 68
7.2 Promising Drugs in Clinical Development 69
7.2.1 Tofacitinib (CP-690550) 70
7.2.2 Tabalumab (LY2127399) 77
7.2.3 Fostamatinib (previously R788) 80
7.2.4 Secukinumab (AIN457) 84
7.2.5 Masitinib (AB101) 88
7.2.6 Baricitinib (formerly LY3009104/INCB28050) 92
7.2.7 Careram/KOLBET (iguratimod/T-614) 96
8 Market Outlook 99
8.1 Japan 99
8.1.1 Forecast 99
8.1.2 Key Events 101
8.1.3 Drivers and Barriers 102
9 Appendix 104
9.1 Abbreviations 104
9.2 Bibliography 106
9.3 Methodology 114
9.4 Forecasting Methodology 114
9.4.1 Diagnosed Rheumatoid Arthritis Patients 114
9.4.2 Percent Drug-treated Patients 115

4. 9.4.3 Drugs Included in Each Therapeutic Class 115
9.4.4 Launch and Patent Expiry Dates 116
9.4.5 General Pricing Assumptions 116
9.4.6 Individual Drug Assumptions 117
9.4.7 Generic Erosion 123
9.4.8 Pricing of Pipeline agents 123
9.5 Physicians and Specialists Included in this Study 124
9.6 Primary Research - Prescriber Survey 124
9.7 About the Authors 125
9.7.1 Analysts 125
9.7.2 Global Head of Healthcare 126
9.8 About GlobalData 127
9.9 Contact Us 127
9.10 Disclaimer 127
1.1 List of Tables
Table 1: Symptoms of Rheumatoid Arthritis 15
Table 2: Treatment Guidelines for Rheumatoid Arthritis 19
Table 3: Top Three Biologics Prescribed for Moderate-Severe Rheumatoid Arthritis by Market 22
Table 4: Treatment Guidelines for Rheumatoid Arthritis 26
Table 5: Product Profile - Enbrel 28
Table 6: 10 year Open-label Safety and Efficacy Trial of Enbrel: Efficacy Results at 11 years for
Completers 29
Table 7: 10 year Open-label Safety and Efficacy Trial of Enbrel: Safety Results Overall 30
Table 8: Enbrel SWOT Analysis, 2012 32
Table 9: Product Profile - Humira 33
Table 10: Humira SWOT Analysis, 2012 35
Table 11: Product Profile - Remicade 37
Table 12: Remicade SWOT Analysis, 2012 39
Table 13: Product Profile - Simponi 41
Table 14: Simponi SWOT Analysis, 2012 43
Table 15: Product Profile - Cimzia 45
Table 16: Cimzia SWOT Analysis, 2012 47
Table 17: Product Profile - Orencia 49
Table 18: Orencia SWOT Analysis, 2012 51
Table 19: Product Profile - Actemra/RoActemra 53
Table 20: Actemra/RoActemra SWOT Analysis, 2012 55
Table 21: Product Profile - Rituxan 57
Table 22: Rituxan SWOT Analysis, 2012 58
Table 23: Product Profile - Methotrexate 60
Table 24: Methotrexate SWOT Analysis, 2012 61
Table 25: Summary of Minor Therapeutic Classes, 2012 62

5. Table 26: Overall Unmet Needs - Current Level of Attainment 63
Table 27: Clinical Unmet Needs - Gap Analysis, 2012 66
Table 28: Rheumatoid Arthritis - Phase Pipeline, 2012 69
Table 29: Comparison of Therapeutic Classes in Development for RA, 2012 70
Table 30: Product Profile - Tofacitinib 71
Table 31: Clinical Trial Locations by Country for Tofacitinib 71
Table 32: ORAL Standard ACR 20 Responses for Tofacitinib vs. Placebo vs. Humira at Month 6
72
Table 33: ORAL Step ACR 20, 50, 70 Responses for Tofacitinib vs. Placebo at Month Six 72
Table 34: Efficacy Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 73
Table 35: Safety Issues Regarding Tofacitinib Determined by FDA Advisory Panel, May 2012 73
Table 36: Tofacitinib Clinical Trial Mortalities as of September 29, 2011 74
Table 37: Tofacitinib SWOT Analysis, 2012 76
Table 38: Product Profile - Tabalumab 77
Table 39: ACR Responses and DAS28 Scores for Tabalumab vs. Placebo at Week 16 78
Table 40: Tabalumab SWOT Analysis, 2012 79
Table 41: Product Profile - Fostamatinib 80
Table 42: ACR Responses and DAS28 Scores for Fostamatinib vs. Placebo at Month Three 81
Table 43: Fostamatinib SWOT Analysis, 2012 83
Table 44: Product Profile - Secukinumab 84
Table 45: Secondary Endpoint Results for Secukinumab vs. Placebo at Weeks 24 and 52 85
Table 46: Secukinumab SWOT Analysis, 2012 87
Table 47: Product Profile - Masitinib 88
Table 48: ACR Responses for Masitinib in the ITT Population (12 Weeks) 89
Table 49: ACR Responses for Masitinib in the ITT Population (12-82 Weeks) 89
Table 50: Masitinib SWOT Analysis, 2012 91
Table 51: Product Profile - Baricitinib 92
Table 52: ACR Responses for Baricitinib + MTX vs. Placebo + MTX at Week 12 93
Table 53: Safety of 4 and 8mg Baricitinib at Week 12 94
Table 54: Laboratory Values of 4 and 8mg Baricitinib at Week 12 94
Table 55: Baricitinib SWOT Analysis, 2012 95
Table 56: Product Profile - Careram 96
Table 57: Careram SWOT Analysis, 2012 98
Table 58: Sales Forecasts ($m) for Rheumatoid Arthritis in Japan 100
Table 59: Key Events Impacting Sales for Rheumatoid Arthritis in Japan, 2012 101
Table 60: Rheumatoid Arthritis Market - Drivers and Barriers in Japan, 2012 102
Table 61: Key Launch Dates 116
Table 62: Key Patent Expiries 116
Table 63: Physicians Surveyed, By Country 124
1.2 List of Figures
Figure 1: Healthy and Arthritic Joint with Rheumatoid Arthritis 11

6. Figure 2: Rheumatoid Arthritis Biologic Drug Targets 13
Figure 3: Diagnosis Criteria for Rheumatoid Arthritis Based on 2010 ACR/EULAR Criteria Point
System 18
Figure 4: Severity of Rheumatoid Arthritis 18
Figure 5: Biologic Treatment Flow Based on Updated 2012 ACR Treatment Recommendations*
21
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in RA, 2012-2022 69
Figure 7: Sales for Rheumatoid Arthritis in Japan by Drug Class 101
Contact: sales@reportsandreports.com for more information.